Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China

Establishment of Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China: a Multicenter Prospective Cohort Study

Appropriate gestational weight gain (GWG) is a key factor in balancing maternal and neonatal needs of nourishment and health, which is especially important in women with gestational diabetes mellitus (GDM). However, there are no specific guidelines for GWG in Chinese pregnant women and even for GDM pregnant women.This project intends to fill in the gaps of this field through multi-center large sample prospective cohort study.

Study Overview

• Status: Recruiting
• Conditions: Gestational Weight Gain

Detailed Description

Inappropriate gestational weight gain (GWG) is an important risk factor affecting adverse pregnancy outcomes. However, the current guidelines for GWG are based on American population and may not apply to pregnant women in China, especially for those with gestational diabetes mellitus (GDM) who have high risk factors. The big gaps in academic-related fields need to be filled.

Our research group has previously found the heterogeneous relationships between GWG and adverse outcomes in GDM women with different abnormal glucose metabolism. Therefore, based on the principles of precision medicine, this project intends to establish for the first time the GWG standard for Chinese pregnant women to optimize the GWG management through a multicenter prospective cohort study. At the same time, specific GWG guidelines applicable to GDM women with different glucose metabolism abnormalities were innovatively constructed. Our study will provide strong evidence for stratified management and precise intervention of GDM pregnant women, which is of great significance to ensure health of both mothers and their offspring.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Zhaoxia Liang, M.D.; Phone Number: 86571-87061501; Email: xiaozaizai@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Women's Hospital School of Medicine Zhejiang University
    • Contact: Zhaoxia Liang, M.D.; Phone Number: 86571-87061501; Email: xiaozaizai@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

Description

Inclusion Criteria:

• Maternal age: 20-49 years;
• Natural conception;
• Single pregnancy;
• Plan to have routine prenatal examinations and give birth in the research center;
• No plan to move within two years;
• No second pregnancy within two years;
• Willing to cooperate with the hospital to follow up after childbirth.

Exclusion Criteria:

• Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.;
• Assisted reproduction;
• Multiple pregnancy;
• Fetus has a known deformity or genetic defects;
• Incomplete clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GDM group; questionnaire survey and clinical follow-up
non-GDM group; questionnaire survey and clinical follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal outcomes	Including pregnancy-induced hypertension, preterm delivery, abortion, delivery way and so on. They are diagnosed by clinicians and the data is gathered from medical records.	Through delivery completion, up to 40 weeks
Neonatal outcomes	Birth weight（in gram), birth height (in centimetre), gestational week (in week) and so on. They are diagnosed by clinicians and the data is gathered from medical records.	Through delivery completion, up to 40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose metabolism index	OGTT results (mmol/L), HbA1c (%) and so on	postpartum 42 days
offspring	weight (in gram), height (in centimetre), feeding situation (breast feeding or artificial feeding) and so on.	postpartum 42 days
annual follow-up results	Annual questionnaire and physical examination, including weight (in kilogram), height (in metre), disease history, diet surveys and so on.	1 or 2 years after delivery

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Principal Investigator: Zhaoxia Liang, M.D., Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: gestational diabetes mellitus; gestational weight gain
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Body Weight Changes; Diabetes Mellitus; Body Weight; Weight Gain; Diabetes, Gestational; Gestational Weight Gain
• Other Study ID Numbers: GWG2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No